Senior Manager, Formulation & Analytical Development

Overview:

The Senior Manager of Formulation & Analytical Development will support the development of new products and maintenance of current commercial products through management of contract research and manufacturing organizations (CRO, CMO).  The ideal candidate has a strong analytical background with experience managing external resources, excellent written and verbal communication skills, is organized and thrives in a fast-paced, small company environment. This position reports directly to the Vice President, Product Development & Engineering and is hybrid, with a minimum of two days a week onsite.

Responsibilities:

  • Oversee analytical test method development and execution of analytical testing at CROs and CMOs, analyze data, and present status and results to management; escalate issues as necessary
  • Plan and oversee execution of formulation and analytical development studies at CRO and CMOs such as forced degradation, stress studies, drug compatibility and leachable studies
  • Manage stability studies per ICH guidelines
  • Establish product and raw material specifications and release testing
  • Organize outsourced resources to support projects and company objectives
  • Integral member of internal scPharmaceuticals CMC teams and external teams with outside vendors and service suppliers.
  • Prepare supporting documentation for regulatory submissions and draft regulatory documents

Education and Experience Requirements:

  • A minimum of a BS in chemistry, a related field or other requisite experience is required. MS preferred
  • 5+ years of experience in the pharmaceutical industry and familiar with managing CRO/CMO
  • Proven ability to development analytical test methods, plan development studies, analyze and present data, draft reports and regulatory documents
  • Knowledgeable with pharmaceutical regulations (ICH, USP) and test methods (HPLC, FTIR, etc.)

Our Values:

  • Accountability: You… See it. Own it. Solve it. Do it. You possess a high degree of personal responsibility with a similar expectation of your team and colleagues.
  • Commitment to Patients: You have a passion for creating strategic, innovative, valuable, and high-quality solutions and products with a hands-on approach.
  • Teamwork: You confer with others to reach resolutions that are acceptable by all parties involved. You can multi-task and productively manage complex situations involving cross functional teams.
  • Integrity: You possess and demonstrate a high level of emotional intelligence and professionalism in your decision making. You unfailingly act with integrity and respect for colleagues, business partners and customers in all business dealings.
  • Value Driven: You produce consistent, high quality and quantity of outputs and meaningful results that contribute to strategic goals.
  • Empowered Communications: You possess and demonstrate strong communication and interpersonal skills.

EEO Statement

scPharmaceuticals is an Equal Opportunity Employer and takes pride in creating and maintaining a diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

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